Key personnel encompass those individuals directly involved in designing the research protocol, conducting informed consent, executing study interventions or procedures, or handling or analyzing data involving human subjects. This list will include the Principal Investigator as well as Co-Investigators, collaborating investigators, study coordinators, etc.

Can a student be the Principal Investigator?

No...At UNTHSC, student investigators are required to have a faculty member as the principal investigator of record.

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How long does a review take?

The length of protocol review depends on adequacy of the information given to the OReC and IRB. Incomplete or unclear information or research documents may delay the review process. The IRB as well as OReC must have sufficient time to carry out an effective and accurate review to ensure subject safety and compliance with federal regulations.

ForExempt category research, review can range from 1-5 business days depending on the information given. In most cases,Expedited review can be completed within 5 - 7 working days, unless needed information is missing or incomplete.

Full Boardprotocols are subject to a longer time period as they are reviewed by a convened Board. This amount of time is in addition to any protocol modifications, clarifications or revisions that may be requested by the Board before granting approval.

Minor modifications (minimal risk) may be handled in an expedited manner. This type of review may take from 1-7 business days depending on the completeness and accuracy of given information.

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What can I do to help the IRB process move quickly?

Submitting a clean, accurate, clear and complete protocol "speeds" the IRB review process. Investigators may call OReC for guidance on the information and documents needed to conduct an effective review. In addition, OReC offers investigators a unique service to facilitate the IRB review process. Investigators may request a "pre-review" from OReC staff before formally submitting to the IRB. Pre-review can identify potential questions and issues that may arise during the review process. Any issues can then be addressed by the investigator prior to IRB submission and may quicken the formal review and approval process. If you are interested in having a pre-review done, please contact us through our main office number or the appropriate OReC Human Research Protection Coordinator (if known). Pre-review is acourtesyservice and is dependent on coordinator availability. Turn-around time for pre-review may take up to 5-7 business days.

Note: Pre-review does not guarantee final formal IRB approval or that no issues or concerns may arise during IRB review.Pre-review is a "guidance" service offered by OReC. It is the IRB that makes final determination.

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Will notification of approval come back to me?

OReC sends IRB Board Actions and documents to the principal investigator or research coordinator (when applicable). For student-oriented research, Board Actions are normally sent to the faculty advisor (principal investigator). However, if the student investigator would like to receive Board Actions or IRB approved documents, please indicate to OReC staff the appropriate mailing address or availability for pick up.

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Will OReC send notification of upcoming Continuing Review to the Principal Investigator?

On behalf of the IRB, OReC does send out acourtesyletter reminding principal investigators about upcoming continuing review. Notification is sent out 1-2 months before set study expiration date. However, it is theprincipal investigator's responsibility(not the IRB) to keep up with every aspect of their study including when to a submit progress report for continuing review.

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When do I need to submit Conflict of Interest (COI) statements?

Expedited and Full Board protocols require the submission of a signedCOIfor all investigators and study personnel who are employed by UNTHSC or UNT Health. Study investigators and key personnel employed by an external organization do not need to submit a COI to the IRB.

Can off-site investigators or key personnel submit their Conflict of Interest forms to OReC via fax or email?

Faxed COI documents are acceptable, but "per" or "on behalf" signatures are not. All documents (originals, copies, or faxes) requiring key personnel signatures must have that person's signature.

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I have a Conflict of Interest. Does this mean I will have trouble getting my study IRB approved?

Having a conflict of interest does not necessarily mean a study automatically will be disapproved. However, the IRB will assess conflict of interest in relation to subject risk. To ensure subject's autonomy and minimize risk, conflict of interest must be clearly and accurately disclosed in the consent form. If the COIaloneincreases risk (to the point that study risks outweigh the benefits), the board may find additional provisions or safeguards are needed in order to approve the study.